QR Group analyzes the impacts of ANVISA’s new rule and guides companies on how to adapt to changes in the regularization process

ANVISA published RDC No. 954/2024, which updates the criteria and procedures for the simplified registration of medicines. The new rule repeals the old RDC No. 199/2006 and comes into force as of October 2024. The goal of the update is to make the process clearer, more standardized, and more aligned with the agency’s current guidelines.

QR Group, a consultancy specializing in health regulation, analyzes the main impacts of the change and how companies can adapt to the new requirements to ensure compliance and fluidity in records.

What changes with RDC 954/2024?

RDC 954/2024 establishes a new framework for medicines that can be registered through simplified means, keeping the focus on:

• Proven safety, efficacy and quality based on national or international reference;

• More objective technical criteria for classification and eligibility;

• Updated petition and technical review procedures;

• Elimination of ambiguities present in the previous rule.

The new regulation seeks to improve the predictability and transparency of processes, especially for generic, similar and dynamized drugs, which already have consolidated data on use and efficacy.

What are the impacts on companies?

The implementation of RDC 954/2024 requires special attention from pharmaceutical companies, especially those that use or intend to use the simplified registration channel:

• Review of technical dossiers according to the new criteria of the standard;

• Verification of the eligibility of medicines according to the new classification;

• Adjustments to the format and content of petitions as of October 2024;

• Training of regulatory teams to operate within the new model.

Companies that anticipate changes will be able to optimize time, avoid rework, and maintain a competitive advantage in future submissions.

How QR Group supports your company in adapting

QR Group offers complete technical support for companies that need to comply with RDC 954/2024 and maintain fluidity in their regulatory processes with ANVISA:

• Technical review of portfolio and dossiers based on the new criteria of the standard;

• Strategic consulting for migration of pending processes;

• Support in filling out and submitting via updated electronic petition;

• Regulatory training and risk mapping for the company’s technical team.

Our commitment is to transform the regulatory update into an opportunity to gain agility and regulatory compliance.

Talk to QR Group

Does your company use ANVISA’s simplified registration channel?
Count on QR Group to adapt your processes to RDC 954/2024 with security, agility, and technical mastery.

Phone: QR Group